An mHealth App to Increase Engagement in Mental Health Services for Depression and Anxiety: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Major depressive and anxiety disorders affect 61 million adults in the United States. People living with mental illness, including depression and anxiety, experience stigma associated with the illness and receiving treatment for their illness. Stigma refers to negative attitudes or beliefs about mental illness or negative behaviors directed toward persons with mental illness. Stigma is a leading and fundamental cause of health inequities. Contact interventions, which are premised on the idea that positive and voluntary contact with persons with mental illness can effectively reduce mental illness stigma, are aimed at reducing stigma and improving health outcomes. Video-based interventions improve knowledge, attitudes, and behavior in the short term, and there is a need for randomized controlled trials of indirect contact or video-based contact interventions to address stigma and engagement in mental health services.

OBJECTIVE: The aim is to assess the feasibility and acceptability and test the preliminary efficacy of a self-administered video-based mobile app in reducing mental illness stigma among Black adults with moderate to severe depression or anxiety.

METHODS: The intervention will involve short videos (6-12 minutes in length) of patients describing personal narratives of mental illness, treatment, and recovery and will be delivered over 4 weeks, with 2 booster sessions in weeks 6 and 12. Study participants (N=90) will be randomly assigned to 1 of 3 treatment arms: a standard video-based app (n=30), a video-based app modified with a concordant patient video (n=30), and a waitlist control (n=30).

RESULTS: We hypothesize the concordant and standard intervention group will have greater mental health service use, lower stigma, and lower mistrust compared to the waitlist arm. As a feasibility study, we will pilot the outcome analyses (to detect a signal and estimate direction of analysis). On the basis of the sample size of 90 (n=30 in each treated group and control group) and power at 72%, we will be able to detect a medium effect size of Cohen d=0.49 at α=.05 for comparing the intervention versus control proportions for any engagement in mental health care services.

CONCLUSIONS: Given the low uptake of mental health services for people experiencing early signs and emerging symptoms of mental illness, efforts to increase early access to mental health services will be met with ongoing substantial barriers to mental health care use if stigma and medical mistrust are left unaddressed. Data from this pilot and feasibility randomized controlled trial will provide critical information about the feasibility and acceptability of this intervention and preliminary efficacy estimates. This study will fill a critical public health gap created by the stigma that leads to delayed diagnosis, delayed entry into mental health treatment, and increased morbidity and mortality related to mental illness.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06316804; https://clinicaltrials.gov/study/NCT06316804.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/81645.